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N62K06-OS14BE-B05

by Leboo Healthcare Products Limited

Ref N62K06-OS14BE-B05Model Microporous Shoe Cover, PE Coated Non-woven Shoe Cover, Half PE Coated Non-woven Shoe Cover, Nonwoven Shoe Cover Machine Made, Nonwoven Shoe Cover Hand Made,Nonwoven Non-Skid Shoe Cover Machine Made, Nonwoven Non-Skid Shoe Cover Hand Made,

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697442484L06QH Basic UDI-DI 06974424842154UDI-DIDate2 Aug 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Microporous Shoe Cover, PE Coated Non-woven Shoe Cover, Half PE Coated Non-woven Shoe Cover, Nonwoven Shoe Cover Machine Made, Nonwoven Shoe Cover Hand Made, Nonwoven Non-Skid Shoe Cover Machine Made, Nonwoven Non-Skid Shoe Cover Hand Made, N62K06-OS14BE-B05
Primary DI / UDI-DI
06974424842154
Basic UDI-DI
697442484L06QH
EMDN Code
T0208 Shoe covers (excluding personal protective equipment - PPE)
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000008521
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No